The purpose of this proposal is to establish an Obstetric-Fetal-Pharmacology Research Unit (OPRU) at the University of Pittsburgh and to summarize the components of the applicant's OPRU. They will demonstrate their willingness to cooperate with other OPRUs to establish a Network of OPRUs to identify and study common problems related to the use of pharmacologic agents during pregnancy. They provide three protocols for assessment by the Network for future exploration. The Pittsburgh OPRU is composed of a large clinical facility (Magee-Womens Hospital) with more than 8000 deliveries and a wide array of women with medical or obstetric complications. A CRC satellite at Magee provides an optimal site for recruitment and study of pregnant women. These clinical facilities are linked to the Center for Clinical Pharmacology (CCP), which provides a core laboratory for classical pharmacology analyses and a pharmacogenetic laboratory for genotyping, mRNA expression and sequencing endpoint measurements. A proteomics laboratory is also linked to the CCP. In addition to these clinical and analytical resources is a breeding rhesus monkey colony housed at Magee-Womens Hospital. A basic science component completes the Pittsburgh OPRU. A diverse group of basic scientists and clinical researchers has been interacting through the CCP and will add considerable breadth and depth to their OPRU. The leadership of the Pittsburgh OPRU provides a diverse and experienced group of researchers with a long history of collaboration and investigation in the area of maternal-fetal pharmacology. The leadership has experience in collaborative endeavors and is prepared to cooperate with other OPRUs to conduct collaborative research.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
1U10HD047905-01
Application #
6831492
Study Section
Special Emphasis Panel (ZHD1-DSR-T (17))
Program Officer
Mattison, Donald R
Project Start
2004-07-01
Project End
2009-04-30
Budget Start
2004-07-01
Budget End
2005-04-30
Support Year
1
Fiscal Year
2004
Total Cost
$637,630
Indirect Cost
Name
Magee-Women's Research Institute and Foundation
Department
Type
DUNS #
119132785
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
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Ryu, Rachel J; Easterling, Thomas R; Caritis, Steve N et al. (2018) Prednisone Pharmacokinetics During Pregnancy and Lactation. J Clin Pharmacol 58:1223-1232
Caritis, Steve N; Hankins, Gary; Hebert, Mary et al. (2018) Impact of Pregnancy History and 17-Hydroxyprogesterone Caproate on Cervical Cytokines and Matrix Metalloproteinases. Am J Perinatol 35:470-480
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Caritis, Steve N; Bastian, Jaime R; Zhang, Hongfei et al. (2017) An evidence-based recommendation to increase the dosing frequency of buprenorphine during pregnancy. Am J Obstet Gynecol 217:459.e1-459.e6
Lemon, Lara S; Zhang, Hongfei; Hebert, Mary F et al. (2016) Ondansetron Exposure Changes in a Pregnant Woman. Pharmacotherapy 36:e139-41
Zhao, Yang; Chen, Hui-Jun; Caritis, Steve et al. (2016) Development and validation of a sensitive liquid chromatographic-tandem mass spectrometric method for the simultaneous analysis of granisetron and 7-hydroxy granisetron in human plasma and urine samples: application in a clinical pharmacokinetic study in Biomed Chromatogr 30:149-54
Caritis, Steve N; Feghali, Maisa N; Grobman, William A et al. (2016) What we have learned about the role of 17-alpha-hydroxyprogesterone caproate in the prevention of preterm birth. Semin Perinatol 40:273-80
Sharma, Shringi; Caritis, Steve; Hankins, Gary et al. (2016) Population pharmacokinetics of 17?-hydroxyprogesterone caproate in singleton gestation. Br J Clin Pharmacol 82:1084-93
Ryu, Rachel J; Eyal, Sara; Easterling, Thomas R et al. (2016) Pharmacokinetics of metoprolol during pregnancy and lactation. J Clin Pharmacol 56:581-9

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